OPTFlow OPT12606-Q10
by EMED Technologies Corporation
OPTFlow OPT12606-Q10 is a Class II device made by EMED Technologies Corporation, cleared under FDA 510(k) K140131 on 3 Apr 2014 and listed in FDA GUDID since 7 Dec 2020 (UDI-DI 10817708021971), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10817708021971 | Date7 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140131 | Date3 Apr 2014 | StatusActive |
Official records
- AccessGUDID record 10817708021971
- FDA 510(k) database K140131
Across registries
- FDA 510(k) K140131 decided 3 Apr 2014 Active
- FDA GUDID UDI-DI 10817708021971 listed 7 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K140131
- Listed FDA GUDID 10817708021971
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OPTFlow
- Generic name
- Mechanical infusion pump administration set
- Model / Ref / Catalog
- OPT12606-Q10
- Primary DI / UDI-DI
- 10817708021971
- 510(k) Number
- FDA product code
- FPA
- GMDN term
- Mechanical infusion pump administration set
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
- Size
- Needle Gauge — 26 GaugeLength — 6 MillimeterLength — 70 CentimeterTotal Volume — 0.28 Milliliter
Similar devices in this category
Other devices filed under Mechanical infusion pump administration set.